Kornimate/medical-research-clean huggingface dataset:
atrial functional mitral regurgitation and tricuspid regurgitation

Conditions: Atrial Fibrillation; Functional Mitral Regurgitation; Functional Tricuspid Regurgitation

Summary: a prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors \& outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation. participant will under go: * baseline echocardiography * cpex echocardiography * blood test: bnp * 1 year follow up echocardiography participants will be stratified into three subgroups: * atrial functional mr * atrial functional tr * mixed mr \& tr

rationale the natural history and risk factors for atrial valve disease are poorly understood and characterised. this study will examine differences between atrial mitral and atrial tricuspid disease and help us understand the natural history of these pathologies. study objectives primary objective * identify \& characterise phenotypes in functional mitral and tricuspid valve regurgitation * identify risk factors for progression of disease and outcome. secondary objective compare the three groups: atrial functional mr, atrial functional tr, and mixed disease, and identify any differences/similarities. primary endpoint effective regurgitant orifice area at 1 year secondary endpoint * progression of valve disease defined as worsening of mitral or tricuspid regurgitation \> 1 grade at 1 year. * functional: new york heart association class, predicted vo2max (\<84%). * heart failure admission within 1 year of recruitment. * mortality. recruitment will take place from the out-patient clinics \& echocardiography laboratory at st bartholomew's hospital

Eligibility criteria:
inclusion criteria: * informed consent * age of 18 years or older * atrial fibrillation * moderate or severe atrial valve disease * adequate 2d echocardiography views including parasternal long axis, short axis, apical two chamber, apical three chamber and four chamber. exclusion criteria: * unwilling or unable to give consent * left ventricular impairment (ejection fraction \< 50%). * primary/organic valve disease
chemotherapy followed by infusion of partially hla matched unrelated donor cells for patients with aml who are ineligible for stem cell transplantation

Conditions: Acute Myeloid Leukaemia

Summary: a phase 1 study of infusion of partially hla matched unrelated donor blood or marrow cells (microtransplantation) following consolidation chemotherapy in patients with aml that are not suitable for allogenic stem cell transplantation.

to determine the safety and tolerability of co-administration of partially hla antigen matched unrelated donor cryopreserved donor lymphocytes (microtransplantation) with chemotherapy for patients with high risk acute myeloid leukaemia ineligible or unsuitable for high dose chemotherapy and stem cell transplantation.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed aml not considered suitable for allogenic stem cell transplant on the basis of age or co-morbidities 2. complete morphological remission following 1-2 cycles of induction chemotherapy consisting of an anthracycline/cytosine arabinoside combination 3. availability of cryopreserved donor stem cells or bone marrow with appropriate hla matching 4. adequate hepatic and renal function 5. estimated life expectancy of at least 6 months 6. patient has given informed consent or in the event of a patient not able to give informed consent, consent has been given according to hospital procedures in force at the time of trial exclusion criteria: 1. patient not in morphological remission following 2 cycles of induction chemotherapy 2. use of fludarabine or other purine analogue during remission induction or use of any major immunosuppressive medication or any other immunomodulatory agent including thalidomide, lenalidomide, or azacitidine immediately prior to concurrent with administration of chemotherapy for aml or during or in the 3 months after administration of partially hla matched 3rd party cells 3. absence of a cryopreserved donor stem cell or bone marrow product with appropriate matching 4. presence of significant hepatic, renal or other major organ dysfunction 5. uncontrolled infection or bleeding prior to commencement of consolidation chemotherapy 6. privately insured in or outpatient on the day the consent is signed and the days that cryopreserved partially hla matched donor cells are infused
the effects of postisometric relaxation technique in female patients with dyssynergic defecation

Conditions: Constipation - Functional; Pelvic Floor Disorders; Pelvic Floor Dyssynergia

Summary: functional bowel diseases are defined as chronic disorders of the gastrointestinal tract characterized by abdominal pain, bloating, tension and/or defecation abnormalities. functional bowel diseases are studied under five headings: functional constipation, functional diarrhea, functional abdominal bloating / tightness and unclassifiable functional bowel disorders. functional constipation is divided into three categories as normal transition-time constipation, slow transition-time constipation and defecation disorders. defecation disorders occur due to improper use of pelvic floor muscles and anorectal muscles or anatomical abnormalities and account for 1/3 of all constipation. defecation disorders characterized by excessive straining, incomplete defecation sensation, difficult and painful defecation are defined as narrowing of the fecal exit path due to involuntary pelvic floor contractions or posterior compartment pelvic organ prolapse. non-pharmacological treatment in the treatment of functional constipation is considered as the first-line treatment and includes information about the nutrition, fiber-liquid consumption, physical activity and toilet training of patients. biofeedback therapy is often recommended in patients with defecation disorders in the literature, and there are studies showing that it is superior to laxative use and placebo applications in the studies conducted. however, the fact that it is difficult and costly to achieve biofeedback treatment, the method used allows movement at a certain angle and does not include the stretching method seems to be a disadvantage. postisometric relaxation technique is used in cases of pain, muscle spasm and movement limitations. people with defecation disorders experience spasms, pain and movement limitations in the pelvic floor muscles. for this reason, the investigators think that the postisometric relaxation technique may be effective in patients with defecation disorders, and it will also provide advantages due to the fact that the method is easily accessible, does not require extra materials and devices, and has a stretching effect. the aim of this study is to investigate the effect of postisometric relaxation technique on constipation severity, quality of life, anal pain, muscle function and sexual function in patients with defecation disorder.


Eligibility criteria:
inclusion criteria: * being the ages between 18-55 * being a women * having been diagnosed with dyssynergic defecation by a physician * not using laxatives exclusion criteria: * having undergone anal region surgery in the last 6 months * having had botox in the last 6 months * being in the menopause period * having been diagnosed with cancer * having a mental problem • having previously received pelvic floor physiotherapy

Keywords: dyssynergic defecation functional constipation pelvic floor physiotherapy pelvic health postisometric relaxation technique
a research study looking at how oral semaglutide works in people with type 2 diabetes in switzerland, as part of local clinical practice

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how rybelsus® works in people with type 2 diabetes and to see if rybelsus® can lower their blood sugar levels. participants will get rybelsus® as prescribed to them by the study doctor. the study will last for about 8-10 months. participants will be asked to complete a questionnaire about how they take their rybelsus® tablets. participants will complete this questionnaire during their normally scheduled visit with the study doctor.


Eligibility criteria:
inclusion criteria: * signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) * diagnosed with type 2 diabetes mellitus * the decision to initiate treatment with commercially available oral semaglutide has been made by the patient/legally acceptable representative (lar) and the treating physician based on local label before and independently from the decision to include the patient in this study * male or female, age above or equal to 18 years at the time of signing informed consent * available hba1c value less than or equal to 90 days prior to the 'informed consent and treatment initiation visit' (v1) or hba1c measurement taken in relation with the 'informed consent and treatment initiation visit'(v1) if in line with local clinical practice * treatment naïve to injectable glucose-lowering drug(s). an exception is short-term insulin treatment for acute illness for a total of less than or equal to 14 days exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * treatment with any investigational drug within 30 days prior to enrolment into the study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
obeticholic acid in pediatric subjects with biliary atresia

Conditions: Biliary Atresia

Summary: this is a phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (ole) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (oca) in pediatric subjects with biliary atresia with successful hepatoportoenterostomy (hpe, also known as a kasai portoenterosomy). the ole will continue to evaluate safety, tolerability, pharmacodynamics, and efficacy of oca. in addition, a change in vitamin a and d levels, and where possible the degree of change in liver stiffness, will be assessed during the ole.


Eligibility criteria:
key inclusion criteria: 1. male or female pediatric subjects ≥2 to \<18 years old 2. diagnosis of biliary atresia 3. demonstrated successful hpe (also known as kasai portoenterostomy) as defined by total bilirubin \<2 mg/dl (34.2 μmol/l) at least 3 months post-hpe procedure. 4. able to swallow tablets (ie, tablet or mini-tablet formulation) key exclusion criteria: 1. prior liver transplant or active status on transplant list 2. conjugated (direct) bilirubin ≥uln of site specific reference range 3. if conjugated bilirubin is not available: total bilirubin ≥2 mg/dl (34.2 μmol/l) 4. platelets \<150,000/μl 5. inr ≥1.5 6. current or history of complications of decompensated chronic liver disease including: 1. high-risk gastroesophageal varices and/or variceal bleeding 2. clinically evident ascites related to portal hypertension 3. hepatic encephalopathy 4. prior placement of portosystemic shunt 5. hepatopulmonary syndrome or portopulmonary hypertension 6. hepatorenal syndrome 7. current intractable pruritus or requires systemic treatment for pruritus within 3 months of screening (e.g., with bile acid sequestrants or rifampicin) 8. height and weight z-score \<-2 per site specific ranges 9. acholic (pale) stools 10. ast \>4x uln 11. alt \>4x uln 12. ggt \>500 u/l 13. anticoagulation therapy 14. albumin \<3.5 g/dl 15. ongoing current cholangitis 16. choledochal cystic disease 17. renal disease defined as serum creatinine \>uln for subject's age, prior to enrollment

Keywords: biliary atresia hepatoportoenterostomy (hpe) kasai portoenterostomy liver obeticholic acid
school nurse intervention and after school exercise program for overweight teens

Conditions: Overweight; Obesity

Summary: adolescent overweight and obesity have increased dramatically in the past several decades. high schools are well-positioned to deliver weight loss treatment to overweight and obese adolescents, as they have the facilities and staff to deliver a physical activity program, school nurses with the skills to provide counseling, and are easily accessible by adolescents. this exploratory study will test the feasibility and ability of a school-based intervention, consisting of school nurse counseling and a school-based exercise program, to reduce bmi and improve dietary quality, physical activity, and sedentary behaviors in overweight and obese adolescents. if effective, this could prove to be a cost-effective and relatively easy intervention to disseminate widely for significant public health impact.


Eligibility criteria:
inclusion criteria: * enrolled in grades 9 - 12 * bmi \> 85th percentile for age/sex * able to understand and participate in the study * able and willing to provide informed assent (adolescent) and consent (parent) * english-speaking with at least one english-speaking parent exclusion criteria: * planning to move out of the area within the next 8 months * medical condition that precludes adherence to study dietary recommendations (e.g., pregnancy, crohn's disease, ulcerative colitis) * diagnosis of a serious psychiatric illness (e.g., psychiatric hospitalization, eating disorder, suicidal) within the past 5 years * genetic or endocrine causes of obesity (e.g., pradi willi, cushing's syndrome) * developmental delay that would prevent participation in the intervention or measurements * prescribed medications associated with weight gain (e.g.,oral steroids) * morbidly obese, defined as weighing \> 300 pounds

Keywords: school nurse overweight obesity counseling intervention exercise
a study to observe clinical effectiveness of canagliflozin 300 mg containing treatment regimens in indian type 2 diabetes participants with bmi>25 kg/m^2, in real world clinical setting

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to observe clinical effectiveness of canagliflozin by mean haemoglobin a1c (hba1c) and body weight changes from baseline to 12 weeks in indian type 2 diabetes participants.


Eligibility criteria:
inclusion criteria: * t2dm participants on a stable anti-hyperglycemic regimen containing one or more anti-diabetic drug for at least 30 days and had hba1c of more than 7 percent (%) at the time of, or within 2 weeks before canagliflozin 300 mg initiation * t2dm participants as confirmed from hospital records * t2dm participant having bmi\>25kg/m\^2 at the time of canagliflozin 300 mg initiation * participants having clinical assessment data (at least glycated haemoglobin a1c \[hba1c\] and body weight) for at least two visits, that is (i.e.) visit at which treatment with canagliflozin 300 mg was initiated or 2 weeks before initiation and follow-up visit at 12 weeks (+-4 weeks) from initiation, in accordance with the usual clinical practice exclusion criteria: * participants with history of autoimmune diabetes (type 1 diabetes mellitus \[t1dm\] or latent autoimmune diabetes in adults \[lada\]), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or gestational diabetes or any off-label use or patient data refusal based on physician discretion * participants with a history of use of other sodium glucose co-transporter 2 (sglt2) inhibitor within 12 weeks (empagliflozin or dapagliflozin)
the effects of music and television on intraoperative hypertensive events in cataract surgery

Conditions: Anxiety; Intraoperative Hypertension; Cataract

Summary: this study investigates whether television viewing or music listening can reduce pre-operative anxiety and improve surgical outcomes for patients undergoing cataract surgery. it aims to determine the effectiveness of these interventions compared to a control group and assess their impact on physiological markers of anxiety as well as the incidence of intra-operative hypertensive events. the key questions that are to be answered are: 1. does watching television before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients? 2. does listening to music before cataract surgery decrease intraoperative hypertensive events and/or pre-operative anxiety in patients?

the study addresses the gap in literature regarding tv viewing's efficacy in ophthalmic surgery anxiety reduction. it aims to provide insights into cost-effective methods for stress reduction and surgical optimization. through voluntary participation and rigorous methodology, it seeks to enhance patient experience and outcomes in ophthalmic surgery. * study design: randomized controlled design with three groups: control, television intervention, or music intervention. * objective: investigate effects of tv viewing and music listening on pre-operative anxiety in ophthalmic surgery. * comparison: compare relaxation effects of tv and music. * participants: aim to recruit 200 per intervention arm from montefiore medical center. * baseline assessment: measure anxiety levels pre-intervention. * interventions: administer tv or music for 20 minutes pre-surgery. * assessment: evaluate anxiety levels and physiological markers pre- and post-intervention. * monitoring: monitor vital signs during surgery and post-operative period. * data collection: document demographic info, medical history, and baseline anxiety. * measurement tools: use visual analog scale (vas) for subjective assessment and physiological markers. * analysis: compare outcomes across intervention arms using statistical tests.

Eligibility criteria:
inclusion criteria: * participants undergoing cataract surgery at montefiore medical center exclusion criteria: * participants with severe hearing loss or speech impairment * participants with vision loss greater than count fingers * participants with uncontrolled hypertension (defined as \>160/\>100 despite use of antihypertensive medication) * participants who do not have the capacity to provide consent or who require a surrogate to provide consent
pharmacokinetics, safety and tolerability of tamsulosin hydrochloride in children with voiding disorders

Conditions: Urination Disorders

Summary: to investigate pharmacokinetics, safety, and tolerability of tamsulosin hydrochloride in children with voiding disorders


Eligibility criteria:
inclusion criteria: * boys and girls with (or a history of) voiding disorders * age: 5 to 15 years * body weight and height ≥ 5 % and ≤95 % of normal using nomograms * signed and dated written informed consent by the parent or guardian and, where appropriate, informed assent by the child, prior to admission into the study in accordance with good clinical practice (gcp) and the local legislation, has been obtained exclusion criteria: * clinically significant abnormalities found at, or before randomization at visit 2 \[i.e., abnormal: vital signs (e.g., hypotension), ecgs, as well as significant findings during the physical examination\], as determined by the investigator * clinically relevant conditions including, but not limited to, the following: gastrointestinal, cardiovascular (e.g., subjects that fall above the 90th percentile according to the blood pressure nomogram in the isf), hepatic, renal, hematologic, metabolic (including diabetes mellitus), immunological, hormonal disorders, respiratory disease or cancer * subjects who had surgery within the last 30 days * diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders * subjects that have a neurological impairment or psychiatric disorder that prevents their comprehension of consent and their ability to comply with the protocol * history of relevant orthostatic hypotension, fainting spells or blackouts. postdural symptoms occurring (e.g., lightheadedness, dizziness, and fainting) with or without a change in blood pressure and / or pulse rate within 6 weeks of visit 2 * relevant acute infections, especially with regards to urinary tract infections or active genitourinary infection * history of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator * subjects with known hypersensitivity to flomax® (tamsulosin hydrochloride) or other alpha-blockers * use of medications classified as cytochrome p450 3a4 (cyp3a4) inhibitors and inducers within 10 days prior to administration of trial drug * intake of drugs with a long half-life (\> 24 hours) within less than 10 half-lives of the respective drug prior to administration * participation in another trial with an investigational drug within 1 month prior to administration or during the trial * inability to comply with dietary regimen of study center * pregnancy or subjects that are breast feeding * all subjects parents and guardians in the investigator's opinion who cannot understand the terms of the informed consent form and subject information
clinical outcomes after bilateral implantation of zeiss at lisa tri and tri toric iol

Conditions: Cataract

Summary: the aim of this study is to evaluate the visual function of patients with bilateral implantation of the iol trifocal zeiss at lisa tri and tri toric by means of visual acuity tests with and without optical correction, sensitivity curve contrast, defocus curve and quality questionnaire visual function (vfq-25).

twenty patients (40 eyes) diagnosed with cataracts and cataract surgery indication will be selected to participate in this study. the surgery will be performed by the same surgeon with 2 week interval between surgery the first and second eye. after approval of the research project by the research ethics committee all patients should understand and sign the informed consent and informed (ic) before surgery. all patients will be operated by conventional phacoemulsification with implantation of intraocular lens provided by the manufacturer. patients will have five study visits, including the preoperative visit, operative visit four postoperative visits. all patients will be submitted to the following routine assessments preoperatively and demographic patient information will be recorded and a detailed medical history will be obtained. * vfq-25 questionnaire * identification of the dominant eye; * visual acuity * refraction * slit lamp examination * tonometry * self-keratometry; * corneal topography; * microscopy speculate * fundus examination. in addition, all routine preoperative measures will be performed. lens power calculations should be performed on both eyes to ensure qualification (lens power within the diopter range (d) available) and prepare for surgery (getting the lens). the emmetropia (± 0.5 d) should be the target of patients.

Eligibility criteria:
inclusion criteria: * patients older than 50 years * cataract diagnosis indicating surgery in both eyes * corneal astigmatism to 12d (at lisa tri toric) * corneal astigmatism less than 0,75d (at lisa tri) * ability to provide consent and clarification for study participation exclusion criteria: * significant irregular corneal astigmatism as shown by corneal topography; * corneal astigmatism up 12d * patients diagnosed with severe visual degenerative disorders (e.g. macular degeneration or other disorder of the retina) * previous corneal surgery; * amblyopia * planning for multiple procedures, including irl, lasik, etc. during surgery or during the study * endothelial dystrophy clinically significant cornea (eg, fuchs dystrophy) * corneal disease activity (eg, herpes simplex, herpes zoster, etc.) * severe diabetic retinopathy * retinal detachment * glaucoma * patients presenting illness or acute conditions or chronic severe that in the opinion of the investigator, would increase the surgical risk or confound the research results * any patient who is taking part in another study involving ocular surgery

Keywords: cataract phacoemulsification at lisa tri toric iol